Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent
NCT ID: NCT07346365
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
358 participants
INTERVENTIONAL
2026-01-01
2032-06-30
Brief Summary
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The primary endpoint is the complication rate that can be clinically attributed to the remaining pancreatic prosthesis or its removal in the study groups. Secondary endpoints are spontaneous removal of the pancreatic stent, length of hospital stay, rate of follow-up examinations per group, influencing factors, and a possible exploratory analysis.
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Detailed Description
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Both the baseline data and randomization are planned on a secure online platform (http://myresearchmanager.com).
Before removing the pancreatic stent, non-invasive diagnostics may be performed in accordance with hospital standards, and endoscopy may be omitted if the pancreatic stent is found to be displaced.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard
Standard time of the removal
standard group
Removal at intervals of 12 hours up to a maximum of 10 days after the index ERCP
Interventional - delayed removal
Stent removal after 1 - 3 months
pancreatic stent removal
Removal of the pancreatic stent after 1 - 3 months after the placement
Interventions
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pancreatic stent removal
Removal of the pancreatic stent after 1 - 3 months after the placement
standard group
Removal at intervals of 12 hours up to a maximum of 10 days after the index ERCP
Eligibility Criteria
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Inclusion Criteria
* informed consent
Exclusion Criteria
* pregnancy/breastfeeding
* Billroth II
18 Years
ALL
No
Sponsors
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SRH Wald-Klinikum Gera GmbH
OTHER
Asklepios Kliniken Hamburg GmbH
OTHER
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
UNKNOWN
Helios Klinikum Krefeld
UNKNOWN
Sana Klinikum Offenbach
OTHER
St. Josef Hospital Bochum
OTHER
University Hospital, Aachen
OTHER
University Hospital, Essen
OTHER
University Hospital Freiburg
OTHER
Münster University Hospital, Germany
UNKNOWN
Medizinische Universitätsklinik Tübingen
UNKNOWN
University of Göttingen
OTHER
University Hospital, Basel, Switzerland
OTHER
Centrum Gastroenterologie Bethanien
UNKNOWN
University Hospital Munich (LMU)
UNKNOWN
Universitätsklinik Würzburg
UNKNOWN
Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Georg Dultz
Senior Physician at Clinic of Gastroenterology, Johann Wolfgang Goethe University Hospital
Locations
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Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Michael FA, Feldmann C, Erasmus HP, Kubesch A, Goerguelue E, Knabe M, Abedin N, Heilani M, Hessz D, Graf C, Walter D, Finkelmeier F, Mihm U, Lingwal N, Zeuzem S, Bojunga J, Friedrich-Rust M, Dultz G. A novel ultrasound-based algorithm for the detection of pancreatic stents placed for prophylaxis of post-ERCP pancreatitis: a prospective trial. Ultraschall Med. 2025 Apr;46(2):177-185. doi: 10.1055/a-2407-9651. Epub 2024 Sep 2.
Dultz G, Gerber L, Zeuzem S, Bojunga J, Friedrich-Rust M. Prolonged retention of prophylactic pancreatic stents is not associated with increased complications. Pancreatology. 2019 Jan;19(1):39-43. doi: 10.1016/j.pan.2018.11.011. Epub 2018 Nov 22.
Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
Other Identifiers
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FloMi2025
Identifier Type: -
Identifier Source: org_study_id
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